FDA: Page 20
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Permission granted by Amylyx Pharmaceuticals
ALS drug developmentALS drug approved by FDA in closely watched decision, marking win for patients, developer
The drug, which will be sold as Relyvrio, showed modest benefits in function and survival in testing. It also became the latest test of the FDA's flexibility toward new therapies for neurological disorders.
By Jacob Bell • Updated Sept. 30, 2022 -
Courtesy of Pfizer
Pfizer, BioNTech seek FDA clearance for updated COVID-19 booster in children
The request, if cleared, would make U.S. kids between 5 through 11 eligible to receive a "bivalent" shot targeting components of the omicron variants currently circulating.
By Delilah Alvarado • Sept. 26, 2022 -
Joe Raedle / Getty via Getty Images
FDA user fee package to be included in bill to fund government, avoid shutdown, senators say
A “practically clean” version of the bill will allow the FDA to continue its review and testing programs, while leaving more ambitious goals to be dealt with in a funding bill later this year.
By Elise Reuter • Sept. 23, 2022 -
Sarah Silbiger via Getty Images
FDA advisers back microbiota-based treatment for gut infection
Committee members voted in support of Rebiotix’s treatment for recurrent C. diff infections of the intestines, a condition with no approved options after antibiotics fail.
By Christopher Newman • Updated Sept. 23, 2022 -
Courtesy of Eli Lilly
Lilly drug wins FDA clearance for gene-mutated solid tumors, regardless of type
The approval is another example of so-called tissue-agnostic indications, which are based on a cancer’s genetic signature rather than where it is in the body.
By Kristin Jensen • Sept. 22, 2022 -
Getty Images
Fennec wins approval of first drug for chemotherapy-induced hearing loss in children
The drug, Pedmark, has been in development for more than two decades and was previously rejected twice by U.S. regulators.
By Christopher Newman • Sept. 21, 2022 -
Courtesy of Bluebird bio
Bluebird wins FDA approval of gene therapy for rare brain disorder
The therapy, called Skysona and cleared to treat cerebral adrenoleukodystrophy, is the product of more than a decade of work by Bluebird. It will cost $3 million per patient.
By Ned Pagliarulo • Updated Sept. 17, 2022 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
FDA, NIH initiative aims to speed development of drugs for ALS, other brain diseases
The public-private partnership plans to bring together scientific experts, private entities and patient groups to better understand certain neurodegenerative disorders and find new treatments.
By Kristin Jensen • Sept. 15, 2022 -
Danielle Ternes/BioPharma Dive
BioMarin reports cancer case in hemophilia gene therapy trial
The development comes three weeks after Roctavian was approved in Europe and ahead of a planned regulatory submission in the U.S. Drug regulators have not ordered a trial hold, however.
By Jonathan Gardner • Sept. 13, 2022 -
Permission granted by Bristol-Myers Squibb
Bristol Myers gets FDA approval for new type of psoriasis drug
Sotyktu has been on the pharma’s top pipeline candidates and its clearance continues a string of positive regulatory news for the company.
By Jonathan Gardner • Updated Sept. 12, 2022 -
Sarah Silbiger via Getty Images
ALS drug developmentHow a top FDA official’s words helped push a closely watched ALS drug toward approval
Comments by Billy Dunn, head of the FDA’s neuroscience office, played a major role in a vote by an advisory panel Wednesday in support of the medicine, which is in the final stages of regulatory review.
By Ned Pagliarulo • Sept. 9, 2022 -
Sarah Silbiger via Getty Images
FDA names new head to vaccine review office
David Kaslow, the lead scientist at a global public health nonprofit, will succeed Marion Gruber, who retired last fall amid her dissent on the timing of COVID-19 vaccine boosters.
By Jonathan Gardner • Sept. 9, 2022 -
Sarah Silbiger via Getty Images
FDA advisers back Amylyx ALS drug, reversing earlier position
Committee members voted 7-2 in support of the experimental medicine, which is under a closely watched FDA review. A decision on approval is expected by the end of the month.
By Jacob Bell • Updated Sept. 7, 2022 -
FDA holds back Alvotech’s Humira biosimilar over manufacturing issues
The company received a complete response letter, but still expects to win approval of the copycat drug in time to launch it in the U.S. next year.
By Jonathan Gardner • Sept. 6, 2022 -
Courtesy of Sanofi
Sanofi, after long research journey, wins FDA approval for rare disease drug
Approval of Xenpozyme, a treatment for a form of Niemann-Pick disease, comes with a valuable priority review voucher for Sanofi.
By Kristin Jensen • Sept. 1, 2022 -
Sarah Silbiger via Getty Images
FDA clears updated COVID-19 boosters from Pfizer, Moderna
The new shots, which are designed to better target circulating strains of omicron, could be available within days.
By Delilah Alvarado • Aug. 31, 2022 -
Photo illustration by Maura Sadovi/BioPharma Dive; photograph by Carl Court via Getty Images
Moderna follows Pfizer in asking FDA to approve updated COVID shot
The companies are moving quickly to supply vaccines targeting currently circulating omicron variants in time for the Biden administration's planned fall vaccination campaign.
By Kristin Jensen • Aug. 24, 2022 -
Carsten Koall via Getty Images
FDA authorizes Novavax’s COVID-19 vaccine for teens
The decision will make a third vaccine available for children 12 to 17 years old in the U.S., giving them an option that doesn’t use the messenger RNA technology of shots by Pfizer and Moderna.
By Christopher Newman • Updated Aug. 22, 2022 -
Mario Tama via Getty Images
Pfizer, BioNTech submit omicron booster for FDA clearance
The revamped shot, which is adapted to the omicron variants now circulating, is key to the Biden administration’s plans for a fall vaccination campaign.
By Ned Pagliarulo • Aug. 22, 2022 -
Sarah Silbiger via Getty Images
Pharvaris studies of rare disease drug put on hold by FDA
The agency suspended two trials of Pharvaris’ experimental treatment for hereditary angioedema after reviewing nonclinical data, the biotech said.
By Ned Pagliarulo • Aug. 22, 2022 -
Getty Images
Axsome rebounds to win FDA approval of depression drug
A year after finding flaws in the biotech’s application, the regulator cleared a treatment some analysts view as a blockbuster-to-be, sending shares up.
By Ben Fidler • Aug. 19, 2022 -
Lisa Maree Williams via Getty Images
New Enhertu approval adds to growing role of well-known cancer target
AstraZeneca and Daiichi Sankyo’s drug is the first medicine cleared for lung tumors with mutations to HER2, a gene known for its link to breast cancers.
By Ben Fidler • Aug. 12, 2022 -
EQRx, in bid to compete, takes on AstraZeneca’s top seller in head-to-head trial
The study could be critical for a medicine EQRx plans to position as a competitor to Tagrisso. The drug is under review in the U.K., a first for EQRx.
By Kristin Jensen • Aug. 11, 2022 -
Hollie Adams via Getty Images
US takes step to expand monkeypox vaccine supply
The FDA authorized a new plan that could lead to a five-fold increase in available doses. European health officials may follow the agency's lead.
By Kristin Jensen • Aug. 10, 2022 -
Getty Images
FDA approves AstraZeneca, Daiichi drug in breast cancer first
Enhertu is the first targeted therapy cleared for breast cancers that are ‘HER2 low,’ a new classification that could change how doctors treat the disease.
By Ned Pagliarulo • Aug. 5, 2022
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